The diagram explaining the relationship between PM processes and design controls (from the Initiating and Planning lecture) indicates that design controls can easily exist in more than one PM process. Design input, output, and planning for example, are shown to come into effect at the end of project initiation and remain active until the beginning of the execution phase. Likewise, design verification and validation is initiated during the execution phase and concludes in the closing phase, which makes sense in terms of being able to make changes to the inputs if the outputs from the execution phase do not match. For example, if an implantable device does not display any immediate adverse effects, it may pass onto the closing phase followed by market where any long-term toxic effects will become more apparent and therefore must be validated. This ability for design controls to flow into multiple PM processes can therefore allow faulty devices to be revised in a way that minimizes risk, such as by applying new labels, changing vendors, changing packaging standards, etc.

Although most projects are designed to allow revisions in the face of unexpected/untimely events, it is usually very costly, inefficient, and ideally avoided. Is there a PM process that prepares corrective action protocols in case any project deviations arise. Are there any design controls present during this phase that can facilitate the revision process? What if verification was only limited to the execution phase, how might that impact a project for a Class I device compared to a Class III?